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FDA 510(k)

SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER

K-Number: K130331 · 2013-07-26

ApplicantSauflon Pharmaceuticals, Ltd.
Decision Date2013-07-26
Product CodeMVN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER is the device name listed in this FDA 510(k) record. The listed applicant is Sauflon Pharmaceuticals, Ltd.. It received FDA 510(k) clearance on 2013-07-26 under 510(k) number K130331. The device is classified under product code MVN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER?

SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER is a medical device that received FDA 510(k) clearance on 2013-07-26. The listed applicant is Sauflon Pharmaceuticals, Ltd.. The 510(k) number is K130331.

When did SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER receive FDA 510(k) clearance?

SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER received FDA 510(k) clearance on 2013-07-26, under 510(k) number K130331.

Who is the listed applicant for SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER?

The FDA 510(k) record lists Sauflon Pharmaceuticals, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER?

The FDA product code for SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER is MVN.

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Other records listing Sauflon Pharmaceuticals, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K130342SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKERK130734SAUFLON MULTIPURPOSE SOLUTIONK052832SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSESK052809SAUFLON FLAT COLOURED LENS CASEK033656SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASEK030278SAUFLON MULTIPURPOSE SOLUTION - NO RUB

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Related Devices (Code: MVN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261812HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact LensHOYA Lamphun , Ltd.K202448DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP MultifocalAlcon Laboratories, Inc.K202036Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP MultifocalAlcon Laboratories, Inc.K112192NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENSBausch & Lomb, Inc.K080632CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENSClearlab SG Pte, Ltd.K080755SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENSBausch & Lomb, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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